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| Sponsored by: |
Sepracor, Inc. |
|---|---|
| Information provided by: | Sepracor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00064415 |
Purpose
The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema |
Drug: arformoterol Drug: Salmeterol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
| Official Title: | A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease |
| Enrollment: | 799 |
| Study Start Date: | June 2002 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Arformoterol tartrate 50 mcg QD
|
Drug: arformoterol
Arformoterol inhalation solution, 50 mcg QD
|
|
2: Active Comparator
Salmeterol 42 mcg BID
|
Drug: Salmeterol
Salmeterol MDI, 42 mcg BID
|
This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria:
Subjects of childbearing potential must be using an acceptable method of birth control.
EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any of the following criteria:
Contacts and Locations
Show 90 Study Locations
More Information
| Responsible Party: | Sepracor ( Arformoterol Medical Director ) |
| Study ID Numbers: | 091-060 |
| Study First Received: | July 8, 2003 |
| Last Updated: | August 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00064415 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Emphysema Neurotransmitter Agents Salmeterol Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Respiration Disorders Anti-Asthmatic Agents Adrenergic Agonists Pulmonary Emphysema |
Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Formoterol Bronchitis Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
|
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Formoterol |
Bronchitis Emphysema Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Pharmacologic Actions Bronchitis, Chronic Autonomic Agents Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |